What is AFSTYLA 500 IU
AFSTYLA is a recombinant, single-chain human coagulation factor VIII concentrate used for the treatment and prevention of bleeding in patients with hemophilia A (congenital factor VIII deficiency).
- Generic name: Lonoctocog alfa
- Formulation: Powder and solvent for solution for injection
- Strength: 500 IU
- Packaging: 1 kit including a powder vial, a 2.5 ml water for injection (WFI) vial, filter transfer device, administration set, and accessories
AFSTYLA is engineered to have a single-chain structure that improves stability and binding to von Willebrand factor, extending its half-life compared to standard recombinant factor VIII products.
- It is used in children and adults.
- Indicated for routine prophylaxis, on-demand treatment, and surgical bleeding management.
- Not used for von Willebrand disease or other bleeding disorders.
How to use AFSTYLA 500 IU
AFSTYLA should be administered under the supervision of a healthcare professional experienced in hemophilia treatment. It is given via intravenous (IV) injection after proper reconstitution.
- Step 1 – Preparation: Bring the powder and solvent to room temperature (not above 37°C). Avoid heating directly.
- Step 2 – Reconstitution: Use the provided filter transfer device to mix the solvent with the powder. Swirl gently until fully dissolved (typically in less than 10 minutes).
- Step 3 – Inspection: Ensure the solution is clear and colorless. Do not use if cloudy or contains particles.
- Step 4 – Injection: Use the included disposable syringe and venipuncture set to administer intravenously. Inject slowly over several minutes (maximum rate per labeling).
- Step 5 – Disposal: Discard used items safely. Follow institutional or local biohazard disposal protocols.
It is crucial to:
- Follow the prescribed dose and schedule
- Document batch numbers for traceability
- Use immediately after reconstitution
Mode of Action AFSTYLA 500 IU
AFSTYLA (Lonoctocog alfa) replaces the missing or deficient coagulation factor VIII in patients with hemophilia A. Its mode of action is rooted in the physiological clotting cascade.
- Factor VIII acts as a cofactor for factor IXa, forming a complex that activates factor X to Xa in the presence of calcium and phospholipids.
- This cascade leads to the transformation of prothrombin to thrombin and ultimately the formation of a stable fibrin clot.
- AFSTYLA’s single-chain design enhances binding to von Willebrand factor, which stabilizes it in circulation and reduces degradation.
- Its recombinant nature reduces the risk of blood-borne pathogen transmission and immunogenicity from plasma-derived products.
The improved stability and extended half-life allow for:
- Less frequent dosing (every other day or 2–3 times per week for prophylaxis)
- More consistent factor VIII activity levels
- Better adherence and quality of life for patients
AFSTYLA 500 IU Interactions AFSTYLA 500 IU
While AFSTYLA (Lonoctocog alfa) is not extensively metabolized like typical pharmaceuticals, there are still important considerations regarding potential interactions.
- Factor VIII inhibitors (neutralizing antibodies): These can develop in some patients and render AFSTYLA less effective or ineffective. Patients should be monitored regularly.
- Antifibrinolytic agents: Drugs like tranexamic acid or aminocaproic acid can be used adjunctively during dental or surgical procedures to reduce bleeding but must be monitored to avoid excessive clotting.
- Other intravenous products: AFSTYLA should not be mixed with other drugs or infusions. Always administer via a separate line or flush thoroughly before and after use.
- Immunosuppressants or immune modulators: In rare cases where inhibitors develop, immune tolerance induction (ITI) protocols may be initiated using agents that may interact or alter response to AFSTYLA.
There are no known food or herbal interactions, but patients should inform their healthcare provider of all medications and supplements being taken.
Dosage of AFSTYLA 500 IU
The dosage of AFSTYLA is individualized based on patient needs, body weight, the severity of bleeding, and factor VIII levels. It is expressed in International Units (IU).
- On-demand treatment:
- Mild bleeding: 20–40 IU/kg
- Moderate bleeding: 30–60 IU/kg
- Severe bleeding: 60–80 IU/kg
- Routine prophylaxis:
- Children & adolescents: 15–50 IU/kg 2–3 times per week
- Adults: 20–50 IU/kg every other day or 3 times per week
- Surgical procedures:
- Minor surgery: 30–60 IU/kg before surgery and daily until healing
- Major surgery: 60–80 IU/kg preoperatively with maintenance doses
Important considerations:
- Monitoring of factor VIII activity may guide dosage adjustments
- Doses should be calculated using actual body weight
- Use within 3 hours after reconstitution
Possible side effects of AFSTYLA 500 IU
Like all medications, AFSTYLA can cause side effects. While most are mild and manageable, some may be serious or require immediate attention.
- Common side effects:
- Headache
- Injection site reactions (pain, redness, swelling)
- Nausea or mild fever
- Less common but serious side effects:
- Development of factor VIII inhibitors (may reduce efficacy)
- Hypersensitivity reactions (rash, urticaria)
- Anaphylaxis (very rare)
- Immunogenicity:
- Inhibitor formation is more common in previously untreated patients (PUPs) than in previously treated patients (PTPs)
Patients should be educated on signs of allergic reactions and the importance of reporting any unusual symptoms promptly.
AFSTYLA 500 IU Contraindications AFSTYLA 500 IU
AFSTYLA is generally well tolerated, but its use is contraindicated in certain clinical situations.
- Known hypersensitivity: Patients with known allergy to Lonoctocog alfa, any excipients in the formulation (e.g., polysorbate 80), or hamster proteins (used in production) should not receive AFSTYLA.
- Active inhibitors: If a patient has high-titer factor VIII inhibitors, AFSTYLA may be ineffective and alternative bypassing agents should be used.
- Severe allergic or anaphylactic reactions: If a severe reaction occurs following administration, further use is contraindicated unless under close supervision.
Caution is advised in patients with:
- History of hypersensitivity to recombinant proteins
- Previous anaphylactic reactions to blood products
Storage of AFSTYLA 500 IU
Proper storage of AFSTYLA is critical to ensure its safety, sterility, and effectiveness.
- Unopened vials:
- Store in a refrigerator at 2°C to 8°C
- Do not freeze
- Keep in the original box to protect from light
- Room temperature storage:
- AFSTYLA may be stored at room temperature (not above 25°C) for a single period of up to 6 months
- Once removed from refrigeration, do not return to refrigerator
- Record the date it was removed to track expiration
- After reconstitution:
- Use immediately, within 3 hours of preparation
- Do not refrigerate after reconstitution
- Do not use if the solution is cloudy or contains particles
Keep all medications out of the reach of children and properly dispose of unused or expired products.
AFSTYLA 500 IU features an exceptional active ingredient renowned for its potent effects, comprising Lonoctocog alfa. This powerful formulation provides a superior solution for addressing diverse health concerns. With 500 IU/Vial concentration and an easily manageable Powder and Solvent for Solution for Injection, it remains a preferred option for countless individuals seeking effective treatment.
Introduction
All you need to know about AFSTYLA 500 IU .
Welcome to Dwaey, specifically on AFSTYLA 500 IU page.
This medicine contains an important and useful components, as it consists of Lonoctocog alfa.
AFSTYLA 500 IU is available in the market in concentration 500 IU/Vial and in the form of Powder and Solvent for Solution for Injection.
CSL BEHRING GMBH is the producer of AFSTYLA 500 IU and it is imported from GERMANY,
The most popular alternatives of AFSTYLA 500 IU are listed downward .
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Active Substance
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Size
1 Kit [1 Glass Vial (Powder) + 1 Glass Vial (2.5 ml WFI) + 1 filter transfer device 20/20 + 1 administration set (1 disposable 5 ml syringe + 1 venipuncture set + 2 alcohol swabs + 1 non-sterile plaster)]
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Indications
- No indications available.
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Type
Powder and Solvent for Solution for Injection
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Company
Frequently Asked Questions
AFSTYLA 500 IU should be stored according to the instructions provided by CSL BEHRING GMBH .
In general, it is recommended to store AFSTYLA 500 IU in a cool, dry place, away from direct sunlight
and out of the reach of children.
The duration of treatment with AFSTYLA 500 IU may vary depending on the condition being treated
and the guidance of your healthcare provider. It is important to follow the prescribed treatment
plan and continue taking AFSTYLA 500 IU for the recommended duration, even if your symptoms improve.
If you have any concerns or questions about the duration of treatment, consult your healthcare provider.
It is important to check with your healthcare provider or read the medication label for specific
instructions regarding alcohol consumption while taking AFSTYLA 500 IU. Some medications, including
AFSTYLA 500 IU, may have interactions with alcohol that can reduce effectiveness, increase side
effects, or pose other risks to your health. It is best to follow the guidance provided by your
healthcare professional.
If you miss a dose of AFSTYLA 500 IU, take it as soon as you remember. However, if it is close
to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing
schedule. Do not take a double dose to make up for a missed one unless advised by your healthcare provider.
No, do not stop taking AFSTYLA 500 IU without consulting your healthcare provider, even if your
symptoms improve. It is important to complete the full course of treatment as prescribed. Stopping
the medication prematurely may lead to a relapse or incomplete resolution of the condition. If you
have concerns about the duration of treatment, consult your healthcare provider for guidance.
It is important to consult your healthcare provider before taking AFSTYLA 500 IU if you are
pregnant or breastfeeding. They will be able to assess the potential risks and benefits based on your
specific situation. Please note that the safety and suitability of AFSTYLA 500 IU during pregnancy
or breastfeeding may depend on the active substance [Active Substance], concentration 500 IU/Vial,
and the specific recommendations of CSL BEHRING GMBH .
The effects of AFSTYLA 500 IU on your ability to drive or operate machinery can vary depending on
the active substance [Active Substance], concentration 500 IU/Vial, and individual factors.
Some medications may cause drowsiness, dizziness, or other side effects that can impair your judgment
or coordination. It is important to read the medication label or consult your healthcare provider to
understand any potential effects on your ability to perform tasks that require alertness.
The instructions for taking AFSTYLA 500 IU with or without food may vary depending on the medication
and the recommendations of CSL BEHRING GMBH . Some medications may be more effective when taken with
food to enhance absorption or reduce stomach irritation, while others may need to be taken on an empty
stomach for optimal absorption. Read the medication label or consult your healthcare provider for specific instructions.
The use of AFSTYLA 500 IU in children or elderly individuals may depend on various factors, including
the specific medication, type Powder and Solvent for Solution for Injection, and the recommendations of CSL BEHRING GMBH . Some
medications may have specific dosing instructions or precautions for these age groups. Consult your
healthcare provider or read the medication label for information regarding the safe and appropriate use
of AFSTYLA 500 IU in children or elderly individuals.
Dwaey
All medical information published on the Dwaey website aims to increase medical awareness and health education among users. However, it is not a substitute for professional medical advice. Always consult with a specialist doctor. We strongly advise against using any information or medicine found on the site without referring to your healthcare provider.
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